The primary users of this device are doctors, nurses, emergency medical technicians, respiratory therapists, and paramedics. Use environments include during transport, in emergency departments or in the recovery room.

Reason for Recall

The firm discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.

Note: This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus ventilator.

Who May be Affected

Pediatric patients requiring ventilators

Health care professionals using this device to provide ventilation

What to do

On May 31, 2016, the firm notified consignees of the problem via an Urgent Medical Device Recall letter. The letter directed consignees to identify and dispose of the affected products.